A.R.C. Pharma

Your expert partner for regulatory affairs

Dossiers

A.R.C. Pharma consultants conduct sound technical and regulatory evaluations, and  have the expertise to write all types of authorisation dossiers, at all stages of the product life cycle. They also handle their submission, whatever the procedures, and ensure a timely and adequate follow-up.

All product types are supported: innovative and biotechnology medicines, chemical drugs, generic drugs, prescription drugs, orphan drugs, pediatric drug, herbal medicine, self-medication drug, medical devices...

Authorisation dossiers

Marketing Authorisation (CTD, NeeS, e-CTD)

  • Pharmaceutical documentation:
    • Writing / update of module 3
    • Variations
    • ASMF (former DMF)
    • Writing of the QOS (module 2.3)
    • Involvement of pharmaceutical experts, if necessary
  • Preclinical and clinical documentation:
    • Preparation, consolidation of modules 4 and 5
    • Writing of the Overviews and Summaries (modules 2.4, 2.5, 2.6, 2.7)
    • Bibliographic research
    • Involvement of preclinical, clinical or pharmacokinetic experts, if necessary
    • Preparation of responses to investigatory measures and potential dossier rejection
  • Renewal of MA dossier (France and EU)
  • Modification of the SPCs and PILs

Authorisation of clinical trials

  • Writing of IMPD
  • Registration on EudraCT database

Orphan drug designation

  • Writing of orphan drug designation dossiers
  • Evaluation of the disease prevalence by our epidemiologists
  • Submission of the dossier to the EMA

Drug establishment registration

  • Initial or modification dossiers
  • Writing and revision of SOPs

Other authorisation dossiers

  • Benefit/risk ratio reassessment
  • Temporary authorisation for use (TAU) and Cohort TAU dossiers, protocol for Therapeutic Use
  • Self-medication / optional medical prescription
  • Expert reports in connection with delisting requests
  • OTC status request
  • CE marking of medical devices

Readability testing

  • Readability testing for patient information leaflets (PILs), package leaflets (PLs), healthcare professionals instructions and educational materials
  • Compliance review and optimisation of materials: PIL writing in compliance with current EU QRD templates (Centralised, Decentralised and Mutual Recognition procedures) and guidelines
  • Preparation of readability reports for authorities, in accordance with EU requirements and standards

Reimbursement and pricing

  • Recommendation of reimbursement and pricing strategy
  • Preparation and writing of dossiers: new registration, renewal, change of registration conditions, reassessment of medical service provided (SMR)
  • Preparation of pricing dossiers: new application, price increase
  • Hospital specific dossiers (“ hors T2A” and “retrocession”)

Advertising

  • Regulatory compliance of promotional materials and corporate documents
  • Regulatory compliance of medical and scientific documents
  • In-depth review of all advertising campaign materials
  • Request for certification (visa publicitaire)

Pharmacovigilance

  • Preparation of PSURs

Liaison with national and European authorities

A.R.C. Pharma ensures formatting and submission of all dossiers (marketing authorisation, pricing and reimbursement, advertising…), and if need be, can be mandated to follow-up your submission. We provide our services for all submission procedures for marketing authorisation: national, decentralised, mutual recognition (France and other member states), and centralised (EMA).

On your behalf, A.R.C. Pharma ensures:

  • Preparation of administrative data/SPC / Product Information Leaflet / labelling (module 1)
  • Outsourcing and supervision of translations
  • NeeS and e-CTD formatting
  • Reprographics and CD-ROMs burning
  • Submission of dossiers to the French (ANSM, HAS, CEPS, CNEDIMTS) and European (EMA, national agencies of other member states) authorities.

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